- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... and Daiichi Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system… more
- BioAgilytix (Boston, MA)
- …experience in pharmaceutical/GxP/regulated environment- Direct hands-on experience with computer systems validation and/or equipment qualifications- Direct ... and applied as appropriate.- Ensure all activities related to maintaining computer systems and equipment within the site QMS follow national/international GxPs… more
- Tris Pharma (Monmouth Junction, NJ)
- …in analytical method development, physical characterization, formulation support, interim validation , pilot release testing and stability testing activities for all ... packages per International Council for Harmonization (ICH)/Food and Drug Administration ( FDA ) guidance and provides technical guidance within and outside R&D for… more
- Novo Nordisk Inc. (Durham, NC)
- …design of cGMP utilities as well as working in a regulated environment ( FDA , cGMP, OSHA) preferred Knowledgeable in black utilities system to include chilled water, ... preferred Understanding of technical documents such as URS, SAT, FAT, validation protocols a plus Understanding of complicated product documentation & standard… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- J&J Family of Companies (Columbus, OH)
- Staff Computer System Validation (CSV) Engineer - 2406213015W **Description** Johnson & Johnson Abiomed is recruiting for a **Staff Computer System ... provide SME support at Abiomed. + Develop and execute validation plans for new and existing GxP computer...other relevant regulatory requirements such as ISO 13485, 82304, FDA CSA Draft Guidance + Excellent analytical and problem-solving… more
- Kelly Services (Wilmington, DE)
- **Kelly Services is actively recruiting for a Computer Systems Validation Specialist for a Long Term Contract opportunity in Newark, DE.** Qualifications: The ... official position title is Computer System Validation (CSV) specialist to support...resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 / 210 / 211.… more
- Amgen (West Greenwich, RI)
- …carry out to Amgen corporate, GxP and SOX compliance requirements + Lead computer validation testing initiates with oversight of project resources and analysis ... work alongside other innovative, driven professionals in this meaningful role. **Specialist Computer Systems Validation Engineer** **Live** **What you will do**… more
- Oberg Industries (Sarver, PA)
- …preferred. + Internal auditing/supplier auditing experience preferred. + Working knowledge of FDA 's Process Validation requirements and methods, (IQ, OQ, PQ) + ... Are you ready to take your validation engineering skills to the next level? Join...devices. This role ensures compliance with regulatory requirements (eg, FDA , ISO 13485, ISO 9001, and AS9100) and internal… more
- Bristol Myers Squibb (Devens, MA)
- …biologics / cell therapy manufacturing facility. + Highly knowledgeable of regulatory validation requirements including FDA , EMA and all other Worldwide ... their personal lives. Read more: careers.bms.com/working-with-us . The Manager, Sr. Validation Engineer I supports the successful implementation of manufacturing and… more
- PCI Pharma Services (Philadelphia, PA)
- …sterilization process. This includes strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification, ... + Strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex...experience + Statistical and Advanced Mathematical Skills + Advanced Computer Skills: Ability to perform the most complex … more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …as needed. + Act as a subject matter expert on part 11 requirements and computer system validation (CSV). + Review and approve validation documentation ... 13485, QSR, etc.). + Competence in Medical Device Development Processes and/or Computer System Lifecycle validation compliance demonstrated by relevant industry… more
- Catalent Pharma Solutions (Bloomington, IN)
- …meet the quality standards and requirements of company policies and FDA regulations. **The Process Validation Manager's responsibilities include managing ... FDA , EMA, PDA, ISPE, and other industry organizations + Understands validation technical disciplines, including equipment, cleaning, computer system … more
- Reynolds American (Winston Salem, NC)
- …deliver validation training + Provide metrics for business reporting + Serve as validation project SME during FDA inspections and Serve as the back-up ... validation SME to present validation framework during FDA inspections **What are...computer systems and common terminology + Experience handling validation activities is preferred + Experience working with manufacturing,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the...required - 1 or More Years Direct dealings with FDA , EMA, PMRA, other regulatory agencies. preferred - 1… more
- Eurofins (Columbia, MO)
- …Specialist to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation ... and maintenance of Quality System support documentation, including, but not limited to, computer system validation SOPs. + Draft templates for High level Risk… more
- Bristol Myers Squibb (Bothell, WA)
- …in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and data ... team. + Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations...cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …+ Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities ... Manager, QA Validation Department: QA Validation Location: Monroe,... standards as they apply to facilities, utilities, equipment, computer systems, cleaning and processes. Additionally, person in this… more
- Curia (Albuquerque, NM)
- …work for release of equipment tested. + Assist in the review of validation protocols for computer related systems, environmental monitoring, process validations ... Engineering, or relevant field + Eight (8) years relevant experience in pharmaceutical validation (aseptic/sterile product facility) + Experience with FDA and EU… more
- Integra LifeSciences (Plainsboro, NJ)
- …or more of the following areas of validation : * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * ... a production setting. **Responsibilities** + Generation and execution of qualification/ validation protocols including the generation, routing and approval of summary… more
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